Another Lot of Propofol Recalled
This recall of propofol because of particulates seen in vials follows a previous one in July 2022.
Hospira, a Pfizer company, is voluntarily recalling a second lot of propofol injectable emulsion, (containing benzyl alcohol) because of visible particulates seen in two vials. Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation.
The lot impacted is EA7470 with an expiration date of June 1, 2023. The product is a 100 mL single patient use glass fliptop vial in a tray of 10 units.
Potential adverse events from exposure include blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur. To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.
This is the second lot recalled because of particulates observed in vials. In July 2022, Hospira recalled lot number DX9067, with an expiration of May 1, 2023.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
